Welcome to our new website! If this is the first time you are logging in on the new site, you will need to reset your password. Please contact us at email@example.com if you need assistance.
Your membership opens the door to free learning resources on demand. Check out the Member Knowledge Center for free webcasts, publications and online courses.
This comprehensive resource covers product change evaluation, postmarket surveillance, audit/inspection compliance, and various other laws and regulations pertaining to maintaining a product on the market.
Hear from leaders around the globe as they share insights about their experiences and lessons learned throughout their certification journey.
Regulatory News | 07 June 2017 | By Michael Mezher
The House Energy and Commerce Committee on Wednesday voted unanimously (54-0) to advance its bill to reauthorize the US Food and Drug Administration's (FDA) user fee programs for prescription and generic drugs, biosimilars and medical devices to the full House.
The committee also adopted several amendments to the version of the bill, known as the FDA Reauthorization Act of 2017, that came out of the health subcommittee on 18 May.
And, in an effort to move the bill forward with bipartisan support, two amendments on off-label communications and one amendment addressing risk evaluation and mitigation strategies (REMS) abuse were withdrawn by their sponsors. Another, which would have allowed drug importation from Canada sponsored by Rep. Peter Welch (D-VT) was voted down.
The bill is considered "must-pass" legislation, as failing to reauthorize the user fee agreements before the current ones expire would lead to massive layoffs at FDA.
"If we do not have this bill to the president's desk in July, not only will thousands of FDA employees be seeking new employment, but desperately needed treatments and cures will not reach patients," said Committee Chairman Greg Walden (R-OR).
Among the amendments adopted by the committee were proposals for risk-based classification for medical device accessories, easing requirements for medical imaging devices and contrast agents, servicing and maintenance of medical devices, a pilot project for active surveillance of medical devices, and a manager's amendment that provides a number of technical changes and strengthens the labeling requirements for over-the-counter hearing aids under the reauthorization bill.
Throughout the markup, Democrats said the committee was passing up an opportunity to address drug pricing in the bill, with Rep. Anna Eshoo (D-CA) asking multiple times for the committee to schedule a hearing on the matter.
The committee did however adopt a "sense of Congress" amendment sponsored by Rep. Jan Schakowsky (D-IL) that encourages Congress and the Department of Health and Human Services (HSS) to commit to working on legislative and administrative actions that could lower the cost of prescription drugs and increase competition in the market.
Tags: User fees, Reauthorization, FDARA